Evaluation of "UroShield" Device Impact Upon Side Effects and Complications of Urinary Catheter Usage

Infectious Clinical Trial

Official title:

Evaluation of "UroShield" Device Impact Upon Side Effects and Complications of Urinary Catheter Usage

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02412891
• Other study ID #: 0116-14-EMC
• Status: Withdrawn
• Phase: N/A
• First received: April 1, 2015
• Last updated: September 28, 2016
• Start date: August 2015
• Est. completion date: August 2017

Study information

• Verified date: September 2016
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Evaluation of "UroShield" device impact upon side effects and complications of urinary catheter usage.

The use of urinary catheters is a common medical practice in the perioperative setting.

As such, it exposes the patient to certain comorbidities, including urinary tract infections.

The infectious process is known to begin with a development of a biofilm on the catheter's surface. This fact makes it an attractive target for UTI prevention technology.

Ultrasound waves were shown to reduce biofilm buildup in-vitro. We plan to determine the efficacy of this method in vivo.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who need to insert a catheter urine as part of their treatment and rehabilitation at the orthopedic ward.

Exclusion Criteria:

1. Patients undergoing an invasive procedure in the past month some urinary tract, or the existence of a well-known structural pathology.

2. patients with a urinary tract infection in the past year.

3. Patients with a urinary tract infection when inserting a catheter.

4. pregnant women.

5. Patients under the age of 18.

6. without judgment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infectious

Intervention

Device:
• UroShield device
The UroShield device is Consists of two units:Actuator and Driver.
• Sham UroShield device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	side effects and complications of urinary catheter usage	the measure is a composite of :complaints related to the uro-genital system, the results of blood and urine tests, monitoring fever, blood pressure and pulse	One Year	Yes